Study identification

PURI

https://redirect.ema.europa.eu/resource/104146

EU PAS number

EUPAS103936

Study ID

104146

Official title and acronym

DARWIN EU® - Background rates of serious adverse events to contextualise safety assessments in clinical trials and non-interventional studies in adolescent and adult patients with severe asthma

DARWIN EU® study

Yes

Study countries

Estonia
Netherlands
Spain
United Kingdom

Study description

During the evaluation of the safety results of a clinical trial in patients with severe asthma, differences in rates of serious adverse events were observed in the experimental treatment arm compared to the control arm. In order to contextualize these differences, a non-interventional study was requested to generate background rates of selected health outcomes in patients with severe asthma, with a disease definition that follows recently conducted clinical trials.
By means of a retrospective cohort study using routinely-collected health data from 5 databases we will investigate the following: (i) To estimate the rate of mortality due to any cause stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. (ii) To estimate the rate of mortality due to fatal infections stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. (iii) To estimate the rate of mortality due to cardiovascular events stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. (iv) To estimate the incidence rate of serious cardiovascular events (but not necessarily leading to death) stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. The study population will consists of all individuals present in the database in the period between 01/01/2015 and 31/12/2022, with at least 1 year of prior history, being diagnosed with severe asthma and fulfilling inclusion and exclusion criteria.
The study period is from 2015-2022. Variables of interest will consist of outcomes, comorbidity, lifestyle factors, measurements and drug exposure data. Participating databases have their data mapped to the OMOP CDM. Participating databases are SIDIAP, IPCI, CPRD Gold, IMASIS and the Estonian Biobank.

Study status

Ongoing
Research institution and networks

Institutions

University of Tartu
Estonia
First published:
01/02/2024
Institution
Educational Institution
Oxford University UK

Networks

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
EU institutional research programme
Study protocol
Initial protocol
English (1006.57 KB - PDF)View document
Updated protocol
English (1 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable